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更新于：2025-08-27
Ecnoglutide
伊诺格鲁肽
更新于：2025-08-27
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
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结构/序列
Sequence Code 452883170
来源: *****
关联
16
项与 伊诺格鲁肽 相关的临床试验NCT07073417
A Multicenter, Randomized, Open-label, Treatment Switching Phase II Study to Evaluate the Efficacy and Safety of XW003 Injection and Semaglutide Injection in Chinese Adults With Obesity
ChiCTR2300075163
Pharmacokinetic Study of XW003 Injection in Subjects with Normal Renal Function and Renal Insufficiency
CTR20232548
XW003注射液在肾功能正常和肾功能不全受试者中的药代动力学研究
100 项与 伊诺格鲁肽 相关的临床结果
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100 项与 伊诺格鲁肽 相关的转化医学
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100 项与 伊诺格鲁肽 相关的专利（医药）
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21
项与 伊诺格鲁肽 相关的文献（医药）2025-06-01Lancet Diabetes & Endocrinology
Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
Article
作者: Guo, Tonglan ; Wen, Binhong ; Guo, Mengying ; Fu, Wenyan ; Tian, Junhang ; Zheng, Qing ; Yang, Ming ; Pan, Hai ; Lian, Qiufang ; Gao, Leili ; Gao, Ge ; Zhang, Yawei ; Ning, Jing ; Wang, Haifang ; Hu, Wen ; Shi, Bimin ; Shi, Xiaoguang ; Wang, Kun ; Ji, Linong ; Xing, Ying ; Lu, Yibing ; Li, Ya ; Li, Yao ; Huang, Chongbing ; Han, Jie ; Li, Qingju ; Jiang, Hongwei ; Yuan, Mingxia ; Xue, Haibo
BACKGROUND:
Ecnoglutide is a novel cyclic adenosine monophosphate (cAMP)-biased GLP-1 receptor agonist currently in development for weight management. We aimed to assess the efficacy and safety of once weekly ecnoglutide versus placebo for the treatment of overweight or obesity in Chinese adults.
METHODS:
This randomised, double-blind, placebo-controlled, phase 3 trial was done at 36 medical centres across China. Eligible adults were aged 18-75 years with overweight or obesity (defined as BMI ≥28 kg/m2 or ≥24 kg/m2 with at least one weight-related comorbidity [prediabetes, hypertension, hyperlipidaemia, metabolic dysfunction-associated steatotic liver disease, obstructive sleep apnoea syndrome, or weight-bearing joint pain]), without diabetes (type 1 or 2). Participants were randomly assigned (3:3:3:1:1:1) via computer-generated random sequencing to receive subcutaneous ecnoglutide (1·2, 1·8, or 2·4 mg) or volume-matched placebo (1·2, 1·8, or 2·4 mg), once weekly, stratified by BMI at screening (≥28 kg/m2 and <28 kg/m2). The coprimary endpoints were percentage change in bodyweight and proportion of participants with a reduction in bodyweight of 5% or more at week 40 (using the treatment policy estimand in the full analysis set). The full analysis set included all randomly assigned participants who were exposed to at least one dose of study drug or placebo according to their assigned treatment group. Safety was assessed in all participants who received at least one dose and had a safety assessment after medication. This study was registered with ClinicalTrials.gov, NCT05813795, and is complete.
FINDINGS:
Between April 5, 2023, and June 20, 2024, 882 participants were screened and 664 were randomly assigned to receive ecnoglutide 1·2 mg (n=166), ecnoglutide 1·8 mg (n=166), ecnoglutide 2·4 mg (n=167), or placebo (n=165). At week 40, the least-squares mean percentage change in bodyweight was -9·1% (SE 0·8) in the ecnoglutide 1·2 mg group, -10·9% (0·9) in the ecnoglutide 1·8 mg group, and -13·2% (0·8) in the ecnoglutide 2·4 mg group versus 0·1% (0·8) in the placebo group, and the respective estimated treatment differences compared with placebo were -9·2% (97% CI -11·0 to -7·5), -11·1% (-13·1 to -9·1), and -13·3% (-15·3 to -11·3), respectively (all p<0·0001). The proportion of participants who achieved at least a 5% reduction in bodyweight at week 40 was 77% in the ecnoglutide 1·2 mg group, 84% in the ecnoglutide 1·8 mg group, and 87% in the ecnoglutide 2·4 mg group versus 16% of participants in the placebo group, and the respective estimated treatment differences versus placebo were 60% (98% CI 50 to 71), 68% (58 to 78), and 70% (61 to 80; all p<0·0001). Treatment-emergent adverse events were observed in 155 (93%) of 166 participants in the ecnoglutide 1·2 mg group, 154 (93%) of 166 participants in the ecnoglutide 1·8 mg group, 156 (93%) of 167 participants in the ecnoglutide 2·4 mg group, and 139 (84%) of 165 participants in the placebo group. The most common adverse events were mild-to-moderate gastrointestinal related events. Ten participants treated with ecnoglutide discontinued treatment due to adverse events.
INTERPRETATION:
In adults with obesity or overweight without diabetes (type 1 or 2), individuals administered ecnoglutide had superior and sustained reduction in bodyweight versus placebo with a favourable safety profile, supporting its potential use for weight management.
FUNDING:
Hangzhou Sciwind Biosciences.
2025-01-01PHARMACOLOGICAL REVIEWS
Emerging pharmacotherapies for obesity: A systematic review
Review
作者: Al Rifai, Jana ; Valenzuela-Vallejo, Laura ; Rhayem, Caline ; Kokkorakis, Michail ; Mantzoros, Christos S ; Mantzoros, Christos S. ; Chakhtoura, Marlene ; Ghezzawi, Malak
The history of antiobesity pharmacotherapies is marked by disappointments, often entangled with societal pressure promoting weight loss and the prevailing conviction that excess body weight signifies a lack of willpower. However, categories of emerging pharmacotherapies generate hope to reduce obesity rates. This systematic review of phase 2 and phase 3 trials in adults with overweight/obesity investigates the effect of novel weight loss pharmacotherapies, compared to placebo/control or US Food and Drug Administration-approved weight loss medication, through searching Medline, Embase, and ClinicalTrials.gov (2012-2024). We identified 53 phase 3 and phase 2 trials, with 36 emerging antiobesity drugs or combinations thereof and 4 withdrawn or terminated trials. Oral semaglutide 50 mg is the only medication that has completed a phase 3 trial. There are 14 ongoing phase 3 trials on glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) (ecnoglutide, orforglipron, and TG103), GLP-1 RA/amylin agonist (CagriSema), GLP-1/glucagon RAs (mazdutide and survodutide), GLP-1/glucose-dependent insulinotropic polypeptide and glucagon RA (retatrutide), dapagliflozin, and the combination sibutramine/topiramate. Completed phase 2 trials on incretin-based therapies showed a mean percent weight loss of 7.4% to 24.2%. Almost half of the drugs undergoing phase 2 trials are incretin analogs. The obesity drug pipeline is expanding rapidly, with the most promising results reported with incretin analogs. Data on mortality and obesity-related complications, such as cardio-renal-metabolic events, are needed. Moreover, long-term follow-up data on the safety and efficacy of weight maintenance with novel obesity pharmacotherapies, along with studies focused on underrepresented populations, cost-effectiveness assessments, and drug availability, are needed to bridge the care gap for patients with obesity. SIGNIFICANCE STATEMENT: Obesity is the epidemic of the 21st century. Except for the newer injectable medications, drugs with suboptimal efficacy have been available in the clinician's armamentarium for weight management. However, emerging alternatives of novel agents and combinations populate the current obesity therapeutic pipeline. This systematic review identifies the state and mechanism of action of emerging pharmacotherapies undergoing or having completed phase 2 and phase 3 clinical trials. The information provided herein furthers the understanding of obesity management, implying direct clinical implications and stimulating research initiatives.
2024-06-02Expert Review of Cardiovascular Therapy
Targeting obesity for therapeutic intervention in heart failure patients
Review
作者: Sato, Ryosuke ; von Haehling, Stephan
INTRODUCTION:
Heart failure with preserved ejection fraction (HFpEF) is a highly heterogeneous syndrome, making it challenging to improve prognosis with pharmacotherapy. Obesity is one of the leading phenotypes of HFpEF, and its prevalence continues to grow worldwide. Consequently, obesity-targeted interventions have attracted attention as a novel treatment strategy for HFpEF.
AREAS COVERED:
The authors review the association between the pathogenesis of obesity and HFpEF and the potential for obesity-targeted pharmacotherapeutic strategies in HFpEF, together with the latest evidence. The literature search was conducted in PubMed up to April 2024.
EXPERT OPINION:
The STEP HFpEF (Semaglutide Treatment Effect in People with obesity and HFpEF) and SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trials recently demonstrated that the glucagon-like peptide 1 analogue, semaglutide, improves various aspects of clinical outcomes in obese HFpEF patients and significantly reduces cardiovascular and heart failure events in non-diabetic obese patients, along with a substantial weight loss. Future clinical trials with other incretin mimetics with more potent weight loss and sub-analyses of the SELECT trial may further emphasize the importance of the obesity phenotype-based approach in the treatment of HFpEF.
100 项与 伊诺格鲁肽 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肥胖 | 申请上市 | 中国 | 2024-12-17 | |
| 肥胖 | 申请上市 | 中国 | 2024-12-17 | |
| 2型糖尿病 | 申请上市 | 中国 | 2024-11-23 | |
| 2型糖尿病 | 申请上市 | 中国 | 2024-11-23 | |
| 糖尿病 | 临床3期 | - | - | |
| 肾功能不全 | 临床1期 | 中国 | 2023-08-21 | |
| 非酒精性脂肪性肝炎 | 临床1期 | 中国 | 2021-06-16 | |
| 阿尔茨海默症 | 临床前 | 中国 | 2023-05-19 |
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临床结果
临床结果
适应症
分期
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临床3期 | 621 | ecnoglutide 0.6 mg | 構壓繭鹽窪衊衊顧糧衊(淵鏇鹹廠糧鬱窪窪醖顧) = 鹹積築鏇繭醖築窪淵窪 範積願衊願齋製鹹選繭 (繭選齋鹽構構繭醖積鹹 ) 更多 | 积极 | 2025-08-22 | ||
ecnoglutide 1.2 mg | 構壓繭鹽窪衊衊顧糧衊(淵鏇鹹廠糧鬱窪窪醖顧) = 蓋醖願齋積淵夢膚鑰繭 範積願衊願齋製鹹選繭 (繭選齋鹽構構繭醖積鹹 ) 更多 | ||||||
NEWS 人工标引  | 临床3期 | - | 願網繭獵選構廠鹽淵鹹(鹽製齋繭鏇艱願襯製醖) = 淵鏇遞繭襯糧憲襯遞衊 廠觸顧糧憲積鬱憲餘壓 (醖獵餘憲襯選顧壓鹽鹹 ) | 积极 | 2025-06-27 | ||
临床3期 | 664 | ecnoglutide 1.2 mg | 齋願獵淵製膚膚繭憲顧(積襯鏇淵憲鏇窪簾繭鑰) = 壓構鹹範鏇簾窪夢廠艱 繭顧膚憲窪醖鏇餘鏇鹽 (壓鏇壓艱蓋憲選齋顧憲, 0.8) 更多 | 积极 | 2025-06-21 | ||
ecnoglutide 1.8 mg | 齋願獵淵製膚膚繭憲顧(積襯鏇淵憲鏇窪簾繭鑰) = 窪齋鑰鏇築齋積糧鏇夢 繭顧膚憲窪醖鏇餘鏇鹽 (壓鏇壓艱蓋憲選齋顧憲, 0.9) 更多 | ||||||
临床2期 | 145 | Ecnoglutide 0.4 mg | 繭顧築壓壓蓋鬱網蓋構(鏇艱簾範醖憲窪獵膚範) = 鏇願鏇構齋夢積製獵簾 淵簾餘網顧糧糧蓋艱構 (醖繭鬱蓋繭壓範餘獵積 ) 更多 | 积极 | 2024-09-27 | ||
Ecnoglutide 0.8 mg | 繭顧築壓壓蓋鬱網蓋構(鏇艱簾範醖憲窪獵膚範) = 選獵醖範夢廠齋觸糧糧 淵簾餘網顧糧糧蓋艱構 (醖繭鬱蓋繭壓範餘獵積 ) | ||||||
临床3期 | 211 | Ecnoglutide 0.6 mg | 選艱廠醖網鏇願製顧糧(願膚壓構製鑰製醖鹽壓) = 鹽鹽餘願鏇遞衊簾鏇醖 蓋築選構廠構鹹淵蓋蓋 (齋鹽顧糧鬱膚觸遞淵願 ) 更多 | 积极 | 2024-06-21 | ||
Ecnoglutide 1.2 mg | 選艱廠醖網鏇願製顧糧(願膚壓構製鑰製醖鹽壓) = 醖衊糧繭壓夢範艱醖齋 蓋築選構廠構鹹淵蓋蓋 (齋鹽顧糧鬱膚觸遞淵願 ) 更多 | ||||||
临床1期 | 56 | (healthy) | 蓋壓齋繭衊遞築糧夢鹽(獵築簾築顧繭繭壓淵餘) = The most common AEs were mild to moderate gastrointestinal events that occurred during dose escalation. 鹹艱鬱衊獵壓繭蓋願膚 (衊襯鏇鹹淵憲夢選顧網 ) 更多 | 积极 | 2024-06-21 | ||
(healthy) | |||||||
NEWS 人工标引 | 临床1期 | 56 | 膚選憲壓醖廠鹽遞窪鹽(襯夢鹽壓糧願網製衊醖) = 最常见的不良事件包括恶心、头痛、腹泻、呕吐和食欲减退，大多数不良事件的严重程度为轻中度，主要发生在剂量递增期 醖蓋憲鑰鹽鬱艱齋壓選 (製蓋衊鬱鏇壓選壓襯壓 ) | 积极 | 2024-01-24 | ||
placebo | |||||||
临床3期 | 211 | Ecnoglutide 0.6 mg | 窪糧壓衊繭繭繭鹽網壓(簾鬱繭選鏇築選鬱衊蓋) = 鹽簾壓獵鑰鏇艱鏇鏇觸 顧淵廠廠顧顧願鏇艱衊 (壓網網鑰夢餘製艱鏇顧 ) 更多 | 积极 | 2024-01-03 | ||
Ecnoglutide 1.2 mg | 窪糧壓衊繭繭繭鹽網壓(簾鬱繭選鏇築選鬱衊蓋) = 鹽艱選膚衊觸觸繭蓋獵 顧淵廠廠顧顧願鏇艱衊 (壓網網鑰夢餘製艱鏇顧 ) 更多 | ||||||
临床1期 | 60 | 夢積糧觸製遞鏇製衊憲(夢積鏇夢鬱鬱網獵網築) = The proportion of participants reporting any AE was similar between cohorts (95.2 to 100% for ecnoglutide vs 90% for placebo). The most frequent AEs were gastrointestinal, including diarrhea and vomiting. No drug-related SAE or drug-related AEs ≥Grade 3 were reported. 鬱廠餘膚網繭膚鬱糧網 (衊觸繭構製鬱鏇觸鬱餘 ) 更多 | 积极 | 2023-06-20 | |||
临床2期 | 145 | 壓簾築築顧鹽獵醖遞獵(鹹醖齋鏇襯製選鹽繭鹹) = 製衊願膚觸艱衊築醖顧 醖醖窪鹽醖鏇醖範獵艱 (構膚窪襯壓廠鏇觸顧獵 ) 更多 | 积极 | 2023-06-20 | |||
壓簾築築顧鹽獵醖遞獵(鹹醖齋鏇襯製選鹽繭鹹) = 窪遞餘觸簾艱簾淵餘夢 醖醖窪鹽醖鏇醖範獵艱 (構膚窪襯壓廠鏇觸顧獵 ) 更多 |
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